ArrhythmiasNCT01651702
Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations
A study testing Carto and Ensite in people with Arrhythmias, run by Rabin Medical Center.
Trial summary
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Carto and Ensite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18- 80.
- Ability to sign informed consent.
- History of one of the following arrhythmias requiring the use of 3D electroanatomical mapping:
- Symptomatic paroxysmal or persistent atrial fibrillation with failed treatment of at least two anti-arrhythmic drugs.
- Ischemic ventricular tachycardia necessitating ablation as per decision of electrophysiologist.
- Symptomatic atrial tachycardia after failed medical treatment.
- Symptomatic idiopathic ventricular tachycardia.
Who cannot join
- Unstable patients not allowing performing procedure more than 2 hours
- Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).
About this study
Official title: Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These two systems has been compared in only a few studies. Recent technical advances resulted in the development of new versions of both systems. To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems. The aim of the study to compare two systems for the use in the ablation of complex arrhythmias.
Read the detailed description
Background:
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. It is nowadays an excepted method especially for complex arrhythmias such as atrial fibrillation and ventricular tachycardia.
The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These mapping systems have helped to decrease procedural complexity, procedure time, and improve safety. The EnSite NavX system uses impedance measurements between the individual catheter electrodes and the patches placed on the patient's chest and abdomen. The CARTO system utilizes magnetic location technology to provide accurate visualization of the magnet sensor-equipped catheter tip.
These two systems has been compared in only a few studies. Different results have been found in simple ablations versus more complex ablation of atrial fibrillation. Recent technical advances resulted in the development of new versions of both systems. Carto Express version allows quicker mapping and reconstruction of heart cavities and great vessels geometry as compared to previous versions of Carto XP. EnSite Velocity system incorporates more precise catheter visualization, and allows quicker mapping as compared to previous version of EnSite.
To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems.
Study design Prospective single-center non-randomized open label comparison study. Primary objective Comparison of Carto Express system vs. EnSite Velocity system for ablation of complex arrhythmias.
End points:
- Procedure duration.
- Fluoroscopy time
- Procedure success -will be measured in terms of the 1-year recurrent arrhythmia rate Study population Patients planned for ablation of complex arrhythmia.
- Conditions
- Arrhythmias
- Being tested
- Carto, Ensite
- Keywords
- Arrhythmia, Electroanatomical mapping
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartoDevice
Group of patients where Carto Express system will be used for electroanatomical mapping.
EnsiteDevice
Group of patients where Ensite Velocity system will be used for electroanatomical mapping.
| Study group | Role | What they receive |
|---|---|---|
| Carto | Active comparator | Patients in whom Carto system will be used Receives: Device: Carto |
| Ensite | Active comparator | Patients in whom Ensite system will be used Receives: Device: Ensite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
Average procedure duration (needle to catheters withdrawal)
Measured: Procedure duration - average expected 2.5 hours
Secondary outcomes (2)
Fluoroscopy time
Average fluro time in each of groups.
Measured: Procedures will be evaluated for the fluoro time, expected average 30 min
Procedure success
Recurrency of the arrhythmia assessed by blinded electrophysiologist
Measured: Patients will be followed for one year for recurrency of arrhythmia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Poor recruit rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Golovchiner, MD, Rabin Medical Center
- Investigators
- Gregory Golovchiner, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651702
- Sponsor's protocol ID
- 0067-12-RMC
- Status last verified
- Apr 2017
- First submitted
- 23 Jul 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias
- ClinicalTrials.gov ID
- NCT01651702
- Acronym / sponsor ID
- 0067-12-RMC
- Conditions
- Arrhythmias
- Keywords
- Arrhythmia, Electroanatomical mapping
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor recruit rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These two systems has been compared in only a few studies. Recent technical advances resulted in the development of new versions of both systems. To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems. The aim of the study to compare two systems for the use in the ablation of complex arrhythmias.
Detailed description
Background:
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. It is nowadays an excepted method especially for complex arrhythmias such as atrial fibrillation and ventricular tachycardia.
The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These mapping systems have helped to decrease procedural complexity, procedure time, and improve safety. The EnSite NavX system uses impedance measurements between the individual catheter electrodes and the patches placed on the patient's chest and abdomen. The CARTO system utilizes magnetic location technology to provide accurate visualization of the magnet sensor-equipped catheter tip.
These two systems has been compared in only a few studies. Different results have been found in simple ablations versus more complex ablation of atrial fibrillation. Recent technical advances resulted in the development of new versions of both systems. Carto Express version allows quicker mapping and reconstruction of heart cavities and great vessels geometry as compared to previous versions of Carto XP. EnSite Velocity system incorporates more precise catheter visualization, and allows quicker mapping as compared to previous version of EnSite.
To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems.
Study design Prospective single-center non-randomized open label comparison study. Primary objective Comparison of Carto Express system vs. EnSite Velocity system for ablation of complex arrhythmias.
End points:
- Procedure duration.
- Fluoroscopy time
- Procedure success -will be measured in terms of the 1-year recurrent arrhythmia rate Study population Patients planned for ablation of complex arrhythmia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carto | Active comparator | Device: CartoPatients in whom Carto system will be used |
| Ensite | Active comparator | Device: EnsitePatients in whom Ensite system will be used |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18- 80.
- Ability to sign informed consent.
- History of one of the following arrhythmias requiring the use of 3D electroanatomical mapping:
Key exclusion criteria (2 listed)
- Unstable patients not allowing performing procedure more than 2 hours
- Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CartoGroup of patients where Carto Express system will be used for electroanatomical mapping. | Device | Carto |
| EnsiteGroup of patients where Ensite Velocity system will be used for electroanatomical mapping. | Device | Ensite |
Primary outcome
Procedure duration
Time frame: Procedure duration - average expected 2.5 hours
Average procedure duration (needle to catheters withdrawal)
2 secondary outcomes
Fluoroscopy time
Time frame: Procedures will be evaluated for the fluoro time, expected average 30 min
Procedure success
Time frame: Patients will be followed for one year for recurrency of arrhythmia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Related trials for Arrhythmias
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Golovchiner, MD principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Carto and Ensite in people with Arrhythmias, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure duration (time frame: Procedure duration - average expected 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.